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FDA 510(k) Application Details - K033546
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
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510(K) Number
K033546
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
NUVASIVE, INC.
10065 OLD GROVE RD.
SAN DIEGO, CA 92131 US
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Contact
LAETITIA BERNARD
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Regulation Number
888.3070
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Classification Product Code
MNH
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More FDA Info for this Product Code
Date Received
11/12/2003
Decision Date
04/12/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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